Evaluating the Efficacy of Perinatal Membrane Allografts in Addition to the Standard of Care for the Treatment of Non-healing Diabetic Foot Ulcers. (NCT06437028)
A Multicenter, Prospective, Randomized Controlled Modified Platform Trial Evaluating the Efficacy of Multiple Cellular, Acellular, and Matrix-like Products (CAMPs) and Standard of Care Versus Standard of Care Alone in the Treatment of Nonhealing Diabetic Foot Ulcers.
🩺 Plain-English Summary (8th-Grade Level)
The goal of this clinical trial is to learn if using perinatal tissue allografts improves healing of chronic, non-healing foot ulcers in diabetic patients. The main question that this study aims to answer is: Does the use of perinatal tissue allografts in conjunction with standard of care wound management techniques result in a higher percentage of target ulcers achieving complete closure (i.e. healing) as compared to ulcers being treated with standard of care alone after 12 weeks of treatment. One ulcer on each participant's foot will receive weekly 1) applications of perinatal tissue allografts and standard of care wound management or 2) standard of care wound management alone. Pictures of the ulcer and measurements of its size will be measured every week to track its healing progress over a total treatment period of 12 weeks. Additionally, the participants will be asked to fill out a questionnaire about the wound impacts their life and their quality of life.
Who can join: Review the eligibility criteria below.
Location: Monroe Biomedical Research — Monroe, North Carolina
Age range: 18 Years
🧪 Interventions in This Study
- Dual-layer perinatal tissue allograft (OTHER)
- Three-layer fenestrated perinatal tissue allograft (OTHER)
- Standard of care (OTHER)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Monroe Biomedical Research — Monroe, North Carolina
📞 Contact the Study Coordinator
Phone: (484) 883-2033
Email: jmercuri@samaritanbiologics.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Diabetic Foot Ulcer
- Omega3 Wound Fish Skin Graft in the Treatment of DFUs — Coconut Creek, Florida
- At-Home Exercise Study for Veterans With Healed Diabetic Foot Ulcers — Baltimore, Maryland
- A Unique Micro Water Jet Technology Device Versus Standard Debridement in the Treatment of Diabetic Foot — San Francisco, California
- Efficacy of ProgenaMatrix™ in the Management of DFUs — Puyallup, Washington
- Clinical Utility of an Amniotic Membrane Allograft for Diabetic Foot Ulcer Wound Management — Palm Springs, California
- NOX1416 in Treatment of Chronic Non-Healing Diabetic Foot Ulcers — Phoenix, Arizona
Explore by condition: All Diabetic Foot Ulcer clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.